Bilevel CPAP, Model 9055 Series
by Sunrise Medical 510(k)
Active
510(k) K032056
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK032056 | Date20 Feb 2004 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- BZD
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.5905
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 6 Oct 2026
The Bilevel CPAP, Model 9055 Series is a non-continuous ventilator designed to provide positive airway pressure. It is intended for use in treating obstructive sleep apnea in spontaneously breathing adult patients.
This device is authorized under FDA 510(k) clearance. It features a circular DIN connector on the back of the unit for the attachment of approved accessories that comply with safety standards.
Other devices from Sunrise Medical
Questions
AI-generated answers, 6 Oct 2026
What is the primary clinical use for the Bilevel CPAP, Model 9055 Series?
The Bilevel CPAP, Model 9055 Series is a non-continuous ventilator designed to provide positive airway pressure. It is specifically indicated for the treatment of obstructive sleep apnea in adult patients who are spontaneously breathing.
How are accessories connected to the device?
The device features a circular DIN connector located on the back of the unit. This connector is designed for the attachment of approved accessories that meet established safety standards.
What is the regulatory status of this device?
This device is authorized under FDA 510(k) clearance, which signifies that it has been reviewed and cleared for market distribution based on its substantial equivalence to legally marketed predicate devices.